Submission Details
| 510(k) Number | K041579 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 14, 2004 |
| Decision Date | April 21, 2005 |
| Days to Decision | 311 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
Cleared
Traditional
MEDELA SINGLE USE SILC CUP, MODEL 077.0791
Apr 2005
Decision
311d
Days
Class 2
Risk
About This 510(k) Submission
K041579 is an FDA 510(k) clearance for the MEDELA SINGLE USE SILC CUP, MODEL 077.0791, a Extractor, Vacuum, Fetal (Class II — Special Controls, product code HDB), submitted by Medela AG (Baar Zug, CH). The FDA issued a Cleared decision on April 21, 2005, 311 days after receiving the submission on June 14, 2004. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4340.
Device Classification
| Product Code | HDB — Extractor, Vacuum, Fetal |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.4340 |
Manufacturer
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